Smart Technology Facilitated Patient-centered Venous Thromboembolism Management
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: mobile venous thromboembolism application (mVTEA).
- Who it may be relevant to
- Registry conditions: Venous Thromboembolism, Digital Health, Health Education. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Smart Technology Facilitated Patient-centered Venous Thromboembolism Management: A Multicenter Cohort Study
Overview
Smart technologies, such as wearable devices, mobile technologies, and artificial intelligence, are being investigated for use in health management. These technologies have the potential to be applied in disease pre-warning, decision-making support, health education, and healthcare maintenance. They are expected to address the challenges in managing thrombosis, improve access to high-quality medical resources in various regions, and enhance the development of a network for thrombosis rescue and treatment prevention. The objective of this study is to observe the long-term effect of mobile venous thromboembolism application (mVTEA) based patient-centered management of venous thromboembolism (VTE) on thromboprophylaxis, and establish a foundation of evidence for managing patients with high-risk VTE.
Interventions
- Device mobile venous thromboembolism application (mVTEA)
mVTEA will assist in the management of patients with high-risk of VTE during the post-hospitalization follow-up phase. The mVTEA's doctor terminal automatically sends VTE-related health education materials in different frequencies and contents based on the patient's knowledge of VTE prevention and treatment, as well as their risk of thrombosis and bleeding during follow-up. In addition, thrombosis physicians on the mVTEA's doctor terminal can deliver health education to patients based on their c
Primary outcome measures
- VTE-related composite event [Time frame: At 1-year follow-up]
Secondary outcome measures (7)
- VTE-KAP questionnaire score [Time frame: At 3, 12, and 24-month follow-up]
- Generic quality of life [Time frame: At 3, 12, and 24-month follow-up]
- VTE events [Time frame: At 3, 6, 12, and 24-month follow-up]
- Major bleeding [Time frame: At 3, 6, 12, and 24-month follow-up]
- VTE-related hospitalization [Time frame: At 3, 6, 12, and 24-month follow-up]
- New-onset of atrial fibrillation or atrial flutter [Time frame: At 3, 6, 12, and 24-month follow-up]
- Death [Time frame: At 3, 6, 12, and 24-month follow-up]
Eligibility criteria
Inclusion criteria
- Inpatients ≥18 years of age at admission;
- At high-risk of VTE at discharge: Padua score ≥4 for medical patients and Caprini score ≥5 for surgical patients;
- Signed informed consent.
Exclusion criteria
- Diagnosis of VTE at discharge;
- Mental disorder or combination of other serious diseases leading to incapacity for independent living;
- Inability to use smartphones, computer tablets and other smart devices;
- Being pregnant or breastfeeding;
- Have participated in similar trials or are undergoing other clinical trials.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
China · 1 center
- Sixth Medical Center of Chinese PLA General Hospital — Beijing
Publications
- Chew HK, Davies AM, Wun T, Harvey D, Zhou H, White RH. The incidence of venous thromboembolism among patients with primary lung cancer. J Thromb Haemost. 2008 Apr;6(4):601-8. doi: 10.1111/j.1538-7836.2008.02908.x. Epub 2008 Jan 17. PMID 18208538
- Kang MJ, Ryoo BY, Ryu MH, Koo DH, Chang HM, Lee JL, Kim TW, Kang YK. Venous thromboembolism (VTE) in patients with advanced gastric cancer: an Asian experience. Eur J Cancer. 2012 Mar;48(4):492-500. doi: 10.1016/j.ejca.2011.11.016. Epub 2011 Dec 12. PMID 22169121
- Henke PK, Kahn SR, Pannucci CJ, Secemksy EA, Evans NS, Khorana AA, Creager MA, Pradhan AD; American Heart Association Advocacy Coordinating Committee. Call to Action to Prevent Venous Thromboembolism in Hospitalized Patients: A Policy Statement From the American Heart Association. Circulation. 2020 Jun 16;141(24):e914-e931. doi: 10.1161/CIR.0000000000000769. Epub 2020 May 7. PMID 32375490
Identifiers
NCT: NCT06350344 · HZKY-PJ-2024-8-2